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In vitro test for the evaluation of individual risk of metastasis in surgically treated women for breast cancer |
Vignatelli L, Negro A, Giovannini T, Pirini G, Trimaglio F, Ballini L |
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Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Vignatelli L, Negro A, Giovannini T, Pirini G, Trimaglio F, Ballini L. In vitro test for the evaluation of individual risk of metastasis in surgically treated women for breast cancer. Bologna: Agenzia sanitaria e sociale regionale, Regione Emilia-Romagna (ASSR). Short Report 5. 2011 Authors' conclusions The technology, providing a genetic signature of the breast cancer tissue, assigns a 10 year level of risk for distant metastasis to women - treated with surgery, LN 0-3 and potentially eligible for adjuvant chemotherapy. The main expected benefit is a more accurate individual estimate of risk for distant metastasis and a reduction in number of patients unnecessarily treated with chemotherapy. However, considering the available data on the individual predictive value of the MammaPrint® and applying them to the population of breast cancer patients of Emilia-Romagna region, the test could not actually obtain any of the expected benefits, besides presenting several important limitations, such as the not negligible amount of technical failure of the test and the difficult management of genetic information, with possible negative psychological repercussions on patients. The ongoing randomized controlled trial, which aims to evaluate the impact of the test on relevant clinical usefulness outcomes, has such serious limitations in the design and rationale that it will be difficult to transfer results to standard clinical practice.
Indexing Status Subject indexing assigned by CRD MeSH Breast Neoplasmss; Neoplasm Metastasis Language Published English Country of organisation Italy English summary An English language summary is available. Address for correspondence Viale Aldo Moro 21, 40127 Bologna, Italia tel. +39 051 5277177 fax +39 051 5277049
Email: Ballini_Lu@regione.emilia-romagna.it AccessionNumber 32014001389 Date abstract record published 24/11/2014 |
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